CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE

{0}------------------------------------------------ K992755 Page 1/3 | SEP 15 1999 | | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 510(k)<br>Summary of Safety and Effectiveness | | Submitter: | Cordis Corporation, a Johnson & Johnson Company<br>40 Technology Drive<br>Warren, New Jersey 07059<br>Telephone: (908) 755-8300<br>Fax: (908) 412-3915 | | Contact Person: | Chuck Ryan<br>Manager, Regulatory Affairs<br>Cordis Corporation, a Johnson & Johnson Company<br>40 Technology Drive<br>Warren, New Jersey 07059<br>Telephone: (908) 412-7446<br>Fax: (908) 412-3915 | | Date Prepared: | August 13, 1999 | | Trade Name: | Cordis PALMAZ® CORINTHIAN™ IQ Transhepatic<br>Biliary Stent | | Common Name: | Biliary Stent and Accessories | | Classification Name: | Biliary Catheter and Accessories (per 21 CFR 876.5010) | | Device Classification: | Class II | # Summary of Substantial Equivalence: The design, material, components, accessories, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent are substantially equivalent to those featured with the predecessor Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stents (see 510(k) #K990631 and K991028). In short, the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent represents a line extension to these predecessor stents. {1}------------------------------------------------ K992755 Page 2/3 #### 510(k) Premarket Notificat ## Device Description: The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is a balloonexpandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis POWERFLEX® Plus and OPTA® LP Balloon Catheters are recommended for the delivery of the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent. The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is mounted upon its recommended balloon catheter delivery device via the use of accessory devices - plastic crimping tubes, which are provided with the packaged stent, and crimping tools, which are provided separately. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and removed. The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is provided sterile and is intended for single use only. #### Intended Use: The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree. #### Technological Characteristics: The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent incorporates the same method of deployment, device and packaging materials, fundamental technology, intended use, and methods of manufacturing and sterilization as those found among the predicate Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stents (see 510(k) #K990631 and K991028). The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent incorporates a slightly modified stent design that is substantially equivalent to that found with these predicate Cordis metal biliary stents. The Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent is provided in a range of nominal, unexpanded lengths from 12 to 18 mm and can be expanded to diameters from 4 to 8 mm. ### Performance Data: The safety and effectiveness of the Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent have been demonstrated via data collected from non-clinical design verification tests and analyses. {2}------------------------------------------------ PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent Cordis Corporation, a Johnson & Johnson Company K992755 page 3/3 510(k) Premarket Notification A statement of substantial equivalence to another product is required by 21 CFR 807.87 and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the stated, "A determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977). {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 5 1999 Mr. Chuck Ryan Manager, Regulatory Affairs Cordis, a Johnson & Johnson Company P.O. Box 4917 Warren. New Jersey 07059 Re: K992755 > Cordis PALMAZ CORINTHIAN IQ Transhepatic Biliary Stent Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: August 13, 1999 Received: August 16, 1999 Dear Mr. Ryan: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent's labeling: The safety and effectiveness of this device for use in the vascular system have not been established. Furthermore, the indication for biliary use must be prominently displayed in all stent labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print. {4}------------------------------------------------ Page 2 - Mr. Chuck Ryan If your device is classified (see above) into either class II (Special Controls) or class III (Premarket II your device is classified (300 above) intil call controls. Existing major regulations affecting your Approval, It thay be subject to saon additions, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice equirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requirements, as seriorin in the Quality byovah seen. regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug regulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Adminstration (1971) will verily back uses. FDA may publish further announcements concerning inay result in regulatory action: In addition, note: this response to your premarket notification your device in the I ederal Register. I issues you might have under sections 531 through 542 of the submission does not any outgation you mages and control provisions, or other Federal laws of regulations. The FDA finding of substantial equivalence of your device to a legally marketed predicate device The I Dri maining of sacctanian oquice and permits your device to proceed to the market. This rosation in a classified.com marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described. Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I herefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling. If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html" Sincerely yours, J. C. X. Susan Alpert, Ph.D., M Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page_lof 1 510(k) Number (if known): K992755 Device Name: _Cordis PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent FDA's Statement of the Indications For Use for device: The Cordis PALMAZ® CORINTHIAN™ IQ Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree. Prescription Use L OR (Per 21 CFR 801.109) Over-The-Counter Use_ Set (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number.